BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP FMRL 7.5MM

    MDR report key: 15414440 · Received September 13, 2022

    Report

    Report Number
    0001825034-2022-02125
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    July 6, 2022
    Report Date
    September 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K050441
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: CUP: 0001825034-2022-02123, HEAD: 0001825034-2022-02124. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02123-1. 0001825034-2022-02124-1. H6:MECHANICAL (G04) STEM VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THERE IS A DARK DISCOLORATION PRESENT ON THE STEM AND IN THE HEAD TAPER. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO RADIOGRAPHIC OSTEOLYSIS. DURING THE PROCEDURE A PSEUDOCAPSULE, HYPERTROPHIC VILLOUS SYNOVIUM, SCAR TISSUE AND GRANULOMATOUS TISSUE WERE ALL EXCISED. IT WAS NOTED THAT CORROSIVE DEBRIS WAS FOUND ON THE TAPER, AND THE HEAD AND TAPER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951730 TAPERLOC MICROP FMRL 7.5MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. NI 018440

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R CAT #: SO31140 - SELEX MAGNUM MOD HDLOT#: 743640| CAT #:US157846 - M2A MAGNUM PF CUPLOT #:451630